Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Device Consultants, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
169 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022895 | ELCAM STOPCOCKS AND MANIFOLDS | Medical Device Consultants, Inc. | 2002-10-18 | 45 | 12 |
| K002699 | PARIETEX COMPOSITE (PCO) MESH | Medical Device Consultants, Inc. | 2001-02-15 | 169 | 0 |
| K002116 | S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 | Medical Device Consultants, Inc. | 2000-08-09 | 27 | 0 |
| K000551 | IMAGE X-70 PLUS DENTAL X-RAY UNIT | Medical Device Consultants, Inc. | 2000-03-16 | 27 | 0 |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | Medical Device Consultants, Inc. | 1997-12-18 | 43 | 0 |
| K864282 | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA | Medical Device Consultants, Inc. | 1987-05-26 | 208 | 0 |
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME | Medical Device Consultants, Inc. | 1986-04-04 | 80 | 1 |
| K860931 | ULTRASUN 3000 AND 5000 SUNTANNING UNIT | Medical Device Consultants, Inc. | 1986-03-28 | 17 | 0 |
| K860929 | ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT | Medical Device Consultants, Inc. | 1986-03-28 | 17 | 0 |
| K860930 | ULTRASUN 2500 SUNTANNING UNIT | Medical Device Consultants, Inc. | 1986-03-28 | 17 | 0 |
| K860932 | ULTRASUN 1000 & 2000 SUNTANNING UNIT | Medical Device Consultants, Inc. | 1986-03-28 | 17 | 0 |
| K853198 | ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES | Medical Device Consultants, Inc. | 1985-10-04 | 66 | 0 |
| K840449 | AMICON DIAFILTER 40. HEMOFILTER | Medical Device Consultants, Inc. | 1984-03-23 | 51 | 0 |
| K821651 | E-Z UP ARTHERAPEDIC CHAIR | Medical Device Consultants, Inc. | 1982-06-24 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda